REGULATORY UPDATE: FDA Clarifies Reporting Requirements Outlined in Blood Donation Suitability Guidance

The Food and Drug Administration issued a revised collection of information today to support the implementation of annual reporting requirements related to the release of unsuitable blood donations from establishments that intend for their activities to fall under the compliance policy outlined in the May 2022 draft guidance, “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements.” The Federal Register notice is scheduled for publication tomorrow.

The draft guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with specific federal regulations under 21 CFR 630.30 regarding donation suitability. AABB summarized these conditions in a May 24, 2022, Regulatory Update. Furthermore, the guidance describes proposed procedures for such an establishment’s filing of annual reports to FDA on the release of unsuitable donations.

Understanding Reporting Requirements

Section III.A of the guidance states that licensed and registered-only blood establishments must maintain records and investigate the error that resulted in the collection of an unsuitable donation, as required by federal regulations. Establishments must also submit a report to FDA annually if they intend for their activities to fall under this compliance policy. These reports should describe the number and type of donations released under these conditions and describe the corrective actions taken to prevent future errors and to ensure regulatory compliance.

During the initial 60-day comment period, FDA received six comment letters in response to the reporting requirements in the proposed guidance. The agency responded to two comments concerning post-donation information (PDI) and whether including corrective actions taken for each error in the annual report would represent duplication of information.

FDA clarified that PDI is beyond the control of establishments and that the agency does not consider the receipt of PDI to be an error that must be reported to the agency on an annual basis, as described in the guidance. However, FDA noted that the blood establishment’s measurement of a donor’s blood pressure, pulse or red blood cell loss are in the control of the establishment. Errors in such measurement would not be identified through PDI.

Regarding duplication of information, FDA stated that establishments may submit the information already developed as part of their deviation management and corrective action program. A new investigation does not need to be completed and new documentation does not need to be created, the agency confirmed.

Finalizing the Guidance

FDA is considering comments as the guidance is being finalized. In addition, the agency will clarify in the final guidance that the annual report about the corrective actions taken may be submitted in summary format. This change in wording did not affect FDA’s estimate of the burden.